Open-Label Treatment With Duloxetine Hydrochloride Once-Daily Dosing for Evaluation of Stabilization Dose in Patients With Major Depression - Full Text View

Open-Label Treatment With Duloxetine Hydrochloride Once-Daily Dosing for Evaluation of Stabilization Dose in Patients With Major Depression

This study has been completed.

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00042562

Purpose

The purposes of this study are to determine:

The safety of duloxetine and any side effects that might be associated with it.

Whether duloxetine can help patients with major depression.

The safety associated with switching from a medication you may be taking for depression to taking duloxetine.

It is possible that information collected during this study will be analyzed by the sponsor in the future to evaluate duloxetine for other possible uses or for other medical or scientific purposes other than those currently proposed.

Condition	Intervention	Phase
Major Depressive Disorder	Drug: duloxetine	Phase III

MedlinePlus related topics:

Depression

ChemIDplus related topics:

Duloxetine Duloxetine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	Open-Label Treatment With Duloxetine Hydrochloride Once-Daily Dosing for Evaluation of Stabilization Dose in Patients With Major Depression

Further study details as provided by Eli Lilly and Company:

Study Start Date:	December 2002
Estimated Study Completion Date:	December 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

You must be at least 18 years old.
You must have been diagnosed with major depressive disorder.
You must be able to visit the doctor's office once a week to once every 2 weeks for a total of 14 weeks

Exclusion Criteria:

You are a woman and are pregnant or breastfeeding.
You have a current or previous major psychiatric disorder other than depression, such as bipolar disorder, schizophrenia, or other psychotic disorder.
You have had a primary diagnosis of an anxiety disorder within the past 6 months.
You have a history of alcohol or drug dependence or abuse within the past 6 months.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00042562

Locations


United States, California

	Los Angeles, California, United States

	Carlsbad, California, United States

	Stanford, California, United States

United States, Connecticut

	Cromwell, Connecticut, United States

United States, Florida

	Coral Springs, Florida, United States

	Gainesville, Florida, United States

	Miami, Florida, United States

United States, Georgia

	Atlanta, Georgia, United States

United States, Maine

	Bangor, Maine, United States

United States, Massachusetts

	Boston, Massachusetts, United States

United States, New York

	Rochester, New York, United States

	New York, New York, United States

United States, Ohio

	Cincinnati, Ohio, United States

United States, Pennsylvania

	Philadelphia, Pennsylvania, United States

	Pittsburgh, Pennsylvania, United States

United States, Texas

	Dallas, Texas, United States

	Houston, Texas, United States

	San Antonio, Texas, United States

United States, Virginia

	Falls Church, Virginia, United States

	Richmond, Virginia, United States

	Charlottesville, Virginia, United States

United States, Washington

	Seattle, Washington, United States

United States, Wisconsin

	West Allis, Wisconsin, United States

Sponsors and Collaborators

Eli Lilly and Company

More Information

Study ID Numbers:	6476, F1J-US-HMBZ
First Received:	July 31, 2002
Last Updated:	July 18, 2006
ClinicalTrials.gov Identifier:	NCT00042562
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:

Depressed

blues

sadness

feelings of guilt

hopelessness

lack of energy

Study placed in the following topic categories:

Dopamine

Depression

Fatigue

Mental Disorders

Mood Disorders

Depressive Disorder, Major

Depressive Disorder

Serotonin

Duloxetine

Behavioral Symptoms

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors

Neurotransmitter Uptake Inhibitors

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Adrenergic Agents

Adrenergic Uptake Inhibitors

Physiological Effects of Drugs

Psychotropic Drugs

Serotonin Uptake Inhibitors

Pharmacologic Actions

Serotonin Agents

Therapeutic Uses

Dopamine Agents

Central Nervous System Agents

Antidepressive Agents

ClinicalTrials.gov processed this record on September 05, 2008